NCT07148778

Brief Summary

The purpose of this clinical study was to evaluate the effectiveness of a web-based "Postpartum Care Package" program developed for postpartum women and delivered via a chatbot, and to examine its effects on the postpartum health of mothers and newborns. The key questions it aims to answer are:

  • What is the impact of the chatbot-supported web-based "Postpartum Care Package" program on the postpartum health of mothers and newborns?
  • Does the chatbot-supported web-based "Postpartum Care Package" program increase women's accessibility and availability of postpartum care resources?

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

August 13, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 13, 2025

Last Update Submit

August 23, 2025

Conditions

Keywords

postpartum care

Outcome Measures

Primary Outcomes (5)

  • Postpartum Physical Symptom Severity Scale

    Maternal physical health will be assessed using the Postpartum Physical Symptom Severity Scale. This four-point Likert-type scale ranges from 0 to 54, with higher scores indicating greater severity of postpartum physical symptoms.

    Pre-test/24-48 hours postpartum Post-test/6 weeks and 3 months postpartum

  • Visual Analog Scale

    Mothers' physical discomfort/pain levels will be assessed using a Visual Analog Scale. The scale consists of a 10 cm horizontal line, where "0" represents no discomfort and "10" represents the most severe discomfort imaginable. Participants will be asked to mark the point on the line that best reflects their level of physical discomfort/pain during the assessment. Higher scores indicate more severe discomfort/pain.

    Pre-test/24-48 hours postpartum Post-test/6 weeks and 3 months postpartum

  • Edinburgh Postpartum Depression Scale

    The Edinburgh Postnatal Depression Scale will be used to screen for depressive symptoms in postpartum women. The scale consists of 10 items on a four-point Likert-type scale. Each item is scored from 0 to 3, and the total score ranges from 0 to 30. Higher scores indicate more depressive symptoms.

    Pre-test/24-48 hours postpartum Post-test/6 weeks and 3 months postpartum

  • Sexual Life Quality Scale

    The Sexual Quality of Life Scale will be used to evaluate the impact of sexual functions on the quality of life of individuals. It assesses physical, emotional, and relational aspects of sexual well-being. This Likert-type scale consists of 18 items. Higher scores reflect better sexual quality of life, while lower scores indicate deterioration in sexual well-being.

    Pre-test/24-48 hours postpartum Post-test/6 weeks and 3 months postpartum

  • Breastfeeding Self-Efficacy Scale

    The Breastfeeding Self-Efficacy Scale will be used to assess mothers' levels of breastfeeding self-efficacy. It evaluates maternal perceptions regarding their skills, knowledge, and coping abilities related to breastfeeding. The scale consists of 14 items rated on a five-point Likert scale. Scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy.

    Pre-test/24-48 hours postpartum Post-test/6 weeks and 3 months postpartum

Secondary Outcomes (1)

  • Postpartum care package program satisfaction

    3rd month postpartum

Study Arms (2)

Arm 1: Chatbot-Assisted Web-Based Postpartum Care Package Program

EXPERIMENTAL
Behavioral: Educational intervention

Arm 2: Standard Postpartum Care

NO INTERVENTION

Interventions

In this study, a web-based postpartum care package program supported by a chatbot will be administered to the intervention group. A pre-test will be administered to participants in the intervention group within 24-48 hours after birth. Participants in this group will be informed that they must watch the videos in the educational modules until the sixth week postpartum. Reminder messages will also be sent to participants via the website, email, and phone calls (between days 7 and 14 postpartum and week 3 postpartum). Participants who have completed the module training will be eligible for post-tests at 6 weeks postpartum and 3 months postpartum.

Arm 1: Chatbot-Assisted Web-Based Postpartum Care Package Program

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIndividuals who are biologically female and in the postpartum period can participate in the study.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Have given birth between the 37th and 41st weeks of pregnancy,
  • Be primigravida,
  • Have not been diagnosed with a high-risk pregnancy,
  • Have an educational level of primary school or above,
  • Have no communication difficulties or mental disabilities,
  • Have access to equipment (mobile phone, computer, tablet, internet) for web-based education,
  • Have experienced no complications in the mother or baby during pregnancy, childbirth, or the postpartum period,
  • Voluntarily agree to participate in the study,

You may not qualify if:

  • Women who moved outside the province where the study was conducted during the implementation period,
  • Women who voluntarily withdrew from the study,
  • Women who did not participate in any phase of the study will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Emine ILKIN AYDIN, Lecturer

    Yozgat Bozok University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine ILKIN AYDIN, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 29, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

There are no plans to share individual participant data (IPD). If data sharing becomes possible in the future, it will be done in accordance with ethical principles and participant confidentiality.